Activity Functions & controls

Operational needs assessment:
To ensure that the considerations are given to
Quality Management Principles
Understanding current and future customer needs and expectation.
Promoting policies and objectives to increase awareness, motivation and involvement of people.
Continual improvement as objective
Planning future of the organization and managing change.
Sequence and interaction of process are designed
Ensuring process inputs, activities and outputs are clearly defined and controlled.
Monitoring inputs and out puts
Identifying and managing risks,and exploiting performance improvement opportunities.
Conducting data analysis
Identifying process owners and giving them full responsibility and authority.
Managing each process
Managing needs and expectation of the interested parties.

Assessment of Needs &expectation of
interested parties ( Customers)
To ensure adequate considerations are given in the organization to customer perceptions. Customers include
Customers and end users
People in the organization
Owners/investors
Suppliers and partners
Society in terms of community and the public

To accomplish the objective
TS identifies the customer valuable to the organization and maintain a balanced response to their needs and expectations
Translate identified needs and expectations into requirements
Communicate the requirements throughout the organization
Focus on process improvement to ensure value for the identified interested parties.


Assessment of Needs
and expectations of the supplier Similarly,
TS monitors needs and expectations of the suppliers
Identify key suppliers and other organizations as potential partners
Jointly establish a clear understanding of customer’s needs and expectations
Jointly establish a clear understanding of partner’s needs and expectations
Set goals to secure opportunities for continuing partnerships
Assessment of needs and expectation of the society In considering its relationships with society
Demonstrate responsibility for health and safety.
Consider environmental impact, including conservation of energy and natural resources
Identify applicable statutory and regulatory requirements , and
Identify the current and potential impacts on society in general , and the local community in particular ,of its products , processes and activities.





Assessment of needs and
expectations of Statutory bodies
In compliance with the rules and regulations, SOPs & SOIs are developed , implemented and monitored.
Resource assessment Resources assessment include people,infrastructure,work environment,information, suppliers and partners, natural resources and financilal resources.

Issues considered in assessment are
Consideration should be given to resources to improve the performance of the organization
Effective efficient, timely provision of resources in relation to opportunities and constraints.
Tangible resources such as improved realization and support facilities.
Intangible resources such as intellectual property.
Resources and mechanism to encourage innovative continual improvement
Organization structure,including project and matrix management needs.
Information management and technology
Enhancement of competence via focused training,education and learning.
Development of leadership skills and profiles for future managers of the organization.
Use of natural resources and the impact of resources on the environment, and Planning for future resource needs
Training assessment
Training assessment consider analysis of both present and expected competence needs as compared to the competence already existing in the organization.

Consideration of the need for competence include
Future demands related to strategic and operational plans and objectives
Anticipated management and work force succession needs
Changes to the organization processes,tools and equipment
Evaluation of competence of individual people to perform defined activities.and
Statutory and regulatory requirements,and standards,affecting the organization and its interested parties.

Planning of education and training needs takes into account of the change caused by the nature of the organizations processes,the stages of development of people and culture of the organization

The objective is to provide people with knowledge and skills which,together with experience ,improve their competence.
Education and training emphasizes the importance of meeting the requirements and needs of the customer and other interested parties. It should also include awareness of the consequences to the organization and its people of failing to meet the requirements.
Training plans include
Objectives, Programme and methods, Resources needed
Identification of necessary internal support.
Evaluation in terms of enhanced competence of people and,
Measurement of effectiveness and impact of the organization

Infrastructure assessment
Assessment include infrastructure necessary for the realization of the products while considering the needs and expectation of the interested parties. The infrastructure should include resources such as plant, work space,tools,and equipment,support services,information and communication technology,and transport facilities.
Assessment of Work Environment Responsibility include the work environment has a positive influence on motivation, satisfaction, performance of people in order to enhance the performance of the organization.
Creation of a suitable work environment as a combination of human and physical factors, consideration of creative work methods and opportunities for greater involvement to realize the potential of the people in the organization.

Safety rules and guidance, including the protective equipment.

Information assessment
Data as fundamental resource for conversation to information and continual development of organization’s knowledge, which is essential for factual decision making and stimulate innovation. In order to manage information,
Identify and access internal and external sources of information.
Convert information to knowledge of use to the organization
Use the data, information and knowledge to set and meet its strategies and objectives.
Ensure appropriate security and confidentiality. and
Evaluate the benefits derived from use of the information in order to improve managing information and knowledge.
Suppliers assessment and validation Optimizing the number of suppliers.
Establishing two-way communication at appropriate levels in both organizations to facilitate the rapid solution of problems, and to avoid costly delays and disputes.
Cooperating with suppliers in validation of its capability of their processes.
Monitoring the ability of the suppliers to deliver conforming products with the aim of eliminating redundant verifications.
Encouraging the suppliers to implement program for continual improvement of performance and to participate in other joint improvement initiatives.
Involving suppliers in the organization’s development activities to share knowledge and effectively and efficiently improve the realization and
Delivery process for conforming products.

Assessment of availability of natural resources
In the Organization considerations are given to the availability of natural resources that influence the performance of the organization. While they are often out of the direct control of the organization,they can have significant positive or negative effects on its results.
The organization has planned, , to ensure to ensure availability of or replacement of these resources in order to prevent or minimize negative affects on the performance of the organization.
Financial planning and assessment
The control of financial Resources include activities for comparing actual usage against plans, and taking corrective actions.
Through improving QMS can influence positively the financial results of the organization.
Internally, by reducing process and product failures, reducing processes, or waste in material and time.
or
Externally, by reducing product failures, costs of compensation under guarantees and warranties, and costs of lost customers and markets. Reporting such matters can also provide a means of determining ineffective or inefficient activities, and initiating suitable improvement actions.

Managing Processes
To develop developed a process control plan for production realization which include
Input and output requirements
(for eg: specification and resources)
Activities with in the process
Verification and validation of processes and products
Analysis of product including dependability
identification, assessment,and mitigation of risk
corrective and preventive action
opportunities and action for process improvements
Control of changes to processes and products
Also include Validation activities include modelling,simulation,and trails,as well as reviews involving customers and other interested parties.
Issues to considered should include Quality poicy and objectives
Process outputs that have been verified against process input requirements, including acceptance criteria, should consider needs and expectation of customers and other interested parties. For verification purposes, the outputs, should be recorded and evaluated against input requirements and accepatance criteria. This evaluation should identify necessary corrective action, preventive actions,or potential improvements in the effectiveness and efficiency of the products. Verification of product can be carried out in the process in order to identify variation.
To undertake periodic review of process performance to ensurethe process is consistent with operating plan
Examples of topics for reviews include
Reliability and repeatability of the process
Identification and prevention of potential nonconformity
Consistency of inputs and outputs with planned objectives potential for improvements and unresolved issues.
To ensure ensure that the validation of products demonstrates that they meet the needs and expectation of the customer and other interested parties.
Capacity and qualification of equipment
Operating conditions of the product
Use or application of the product
Disposal of the product
Product life cycle
Environmental impact of the product, and
Impact of the use of natural resources including materials and energy
These processes should include identification and review of relevant information and should actively involve customers and other interested parties.
Examples of relevant process information include
Requirement of customers and other interested parties
Market research, including sector and end user data
Contract requirements
Bench marking
Process due to statutory and regulatory requirements



Supporting Operation and Realization process To improving the effectiveness and efficiency of the realization process and associated support process, such as
Reducing Waste
Communicating and recording information
Developing supplier capability
Improving Infrastructure
Preventing problems
Processing methods and process yields and
Methods of monitoring
To plan and carry out production and service provisions under controlled conditions such as
Availability of Information that describes characteristics of the product
Availability of Work Instructions
The use of suitable equipments
Availability and use of monitoring and measuring devices
Implementation of monitoring and measuring
Implementation of release, delivery and post delivery activities.
Measurement To ensure effective and efficient measurement, collection and validation of data to ensure the organization’s performance and the satisfaction of other interested parties.Which include review of the validity and purpose of measurements and the intended use of data to ensure added value to the organization.
Continual improvement To provide a structure for improvement activities,
Define and implement a process for continual improvements that can be applied to realization and support processes and activities.
to ensure the effectiveness and efficiency of the improvement process, consideration should be given to realization and support processes in terms of
Effectiveness( such as output meeting requirements)
Efficiency ( Such as resources per unit in terms of time and money)
external effects( Such as statutory and regulatory changes)
Potential weakness( Such as lack of capability and consistency)
the opportunity to employ better methods
Control of planned and unplanned change
Measurement of planned benefits.